Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Inclusion Criteria

• •Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed.
• •Patient is 18 to 80 years of age at the time of consent (inclusive).
• •Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
• •Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
• •Patient is deemed operable per standard institutional criteria.
• •BE lesion length \<6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0.
• •One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii)
• •BE lesion within the treatment zone should be flat