Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated (treatment naïve) Barrett's Esophagus (BE)
• Low- or high-grade non-nodular, previously untreated (treatment naïve) dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
• BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1
• Older than 18 years of age at time of consent
• Operable per institution's standards
• Provides written informed consent on the approved informed consent form
• Willing and able to comply with study requirements for follow-up