Paclitaxel Coated Balloon for the Treatment of Chronic BEnigN STricture- Esophagus

Inclusion Criteria:

1. Age ≥ 22 years

2. Diagnosis of a benign esophageal stricture with at least 2 previous dilations

3. Ogilvie Dysphagia Score of ≥2

4. Minimum esophageal lumen diameter <13 mm

5. Willing and able to complete protocol required follow-up visits

6. Willing and able to provide written informed consent

7. Strictures ≤5cm in total length

8. Target benign esophageal stricture etiologies include:

9. Peptic stricture,

10. Schatzki's ring,

11. Stricture due to prior infection,

12. Post-procedural (e.g. ESD/EMR/RFA/Cryo) stricture

13. Post surgical (e.g. anastomotic), including post curative esophagectomy with orwithout prior neoadjuvant chemoradiation therapy

Exclusion Criteria:

1. Two or more clinically significant (e.g. non-traversable) strictures with totallength >5cm or unable to be treated with a single balloon.

2. Female subjects who are pregnant or breastfeeding or plan to become pregnant in next 12 months

3. Contraindication to endoscopy, anesthesia or deep sedation

4. Benign esophageal stricture due to extrinsic esophageal compression, causticingestion, lichen planus, and purely radiation induced strictures post head/neckcancer treatment.

5. History of diagnosis of eosinophilic esophagitis (EoE)

6. Signs or suspicion of a malignant esophageal stricture NOTE: If stricture issuspicious for malignancy based on clinical or endoscopic presentation, malignancymust be excluded by biopsy prior to enrollment. Subjects with a history of invasiveesophageal cancer should have recurrence excluded by advanced imaging (e.g. CT/PETscan) and biopsy within 6 months of enrollment.

7. Diagnosis of metastatic cancer of any type that is not considered in remission ornon-metastatic cancer that may require radiation treatment in the neck or thoracicregion NOTE: A prior diagnosis of esophageal cancer is acceptable if considered inremission and recurrence has been excluded by advanced imaging and biopsy within 6months of enrollment.

8. Suspected perforation of gastrointestinal tract

9. Inability to pass guidewire across stricture

10. Active systemic infection

11. Allergy to paclitaxel or structurally related compounds

12. Severe coagulation disorders or current use of anticoagulant or antiplateletmedication that cannot be safely managed per recommended guidelines prior to theindex procedure

13. Chronic systemic steroid use for any medical conditions unless subject is willing toundergo a 4-week washout and discontinue steroid use

14. Received steroid injections into target stricture in the last 8 weeks.

15. Stricture not amenable to endoscopic dilation to ≥ 18 mm in the opinion of theinvestigator

16. Current use of nasal or oral feeding tube unless tube is removed prior to baselineassessments and subject maintains normal swallowing function.

17. Acute stricture condition that requires emergent procedure (e.g. immediate dilation)

18. Stricture complicated with abscess, fistula, deep ulceration, perforation, leakageor varices, or thrombosis, etc

19. Life expectancy of less than 24 months

20. Concurrent medical condition that would affect the investigator's ability toevaluate the patient's condition or could compromise patient safety, such as recentmyocardial infarction, severe pulmonary disease, bleeding diathesis, large thoracicaneurysm, pharyngeal or cervical deformity, ongoing infection, etc

21. Current participation in another pre-market drug or medical device clinical studythat has not reached it's primary endpoint.

22. Dysphagia related to primary motility disorders, such as achalasia, diffusedesophageal spasm, ineffective esophageal motility (IEM), hypertensive loweresophageal sphincter, esophageal outlet obstruction, etc.

23. Active erosive esophagitis with a Los Angeles classification of Grade B-D at thetime of endoscopy.

24. Significant esophageal dilation proximal to the stricture that, in theInvestigator's opinion, may impact long-term esophageal motility.

25. Intolerant to effective acid suppression medication (e.g. proton pump inhibitors, H2receptor antagonists)

26. Concurrent gastric and/or duodenal obstruction