Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

The purpose of this study is to evaluate the histological results of a cryoablation technique
used to ablate human esophageal mucosa. The performance and safety of the cryoablation
technique will also be evaluated.

Inclusion Criteria:

- Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory
columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A
patient may be treated with up to 2 zones of ablation.

- Patient is 18 to 80 years of age at the time of consent (inclusive).

- Patient has provided written Informed Consent Form (IFC) using a form 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's esophagectomy is clinically necessary due to reasons unrelated to this
study.

- Patient is deemed operable per standard institutional criteria.

Exclusion Criteria:

- Patient has a known history of unresolved drug or alcohol dependency that would limit
ability to comprehend or follow instructions related to IFC, post treatment
instructions or follow-up guidelines.

- Patient refuses or is unable to provide written informed consent. - -

- Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from
the proposed treatment area including, but not limited to cryospray therapy, laser
treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal
resection, radiofrequency ablation or argon plasma coagulation.

- Patient has esophageal narrowing limiting access to the intended site of ablation.

- Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC
below normal by institutional criteria or standards).

- Patient is undergoing or has recently undergone radiation therapy which involved the
esophagus (within 15 days or WBC below normal by institutional criteria or standards).