trūFreeze® Palliative Esophageal Cancer

The use of cryotherapy delivered with the trūFreeze® System via noncontact spray ablates the
cancer cells while allowing adjacent normal tissue to regenerate. When the liquid nitrogen is
delivered to the malignant lesion the cancer cells undergo ablation induced by intracellular
water being frozen in place such that ice crystals are formed. These ice crystals aggregate
quickly causing immediate intracellular energy producing organelles to be destroyed leading
to a non-viable cell. Subsequent tumor sloughing and absorption of apoptotic cells occurs
with a subsequent debulking of the tumor mass. Normal tissue will regenerate as
re-epithelialization occurs. The extreme cold of -196 degrees Celsius or a "hard freeze"
leads to more extensive primary cell death over a shorter freeze time as compared to
cryoprobes. A reduction of overall tumor obstruction in the esophageal lumen can reduce
symptoms of dysphagia, delay the time until stent is needed, provide palliative care for
patients for whom additional tri-modal therapies are not an option, and may increase quality
of life in esophageal cancer patients. The studies conducted to date have provided
documentation of the safety and effectiveness of spray cryotherapy (SCT) when used for
malignancies in the esophagus. Measures of dysphasia relief have been described in peer
reviewed literature. This study aims to provide much needed HRQOL information as well as
additional tumor characteristics before and after SCT. A cohort of patients with locally
persistent esophageal cancer will be studied in up to twelve (12) centers in the United
States to provide important HRQOL data and more a comprehensive understanding of clinical
tumor response post SCT. In the proposed study, the trūFreeze® System spray cryotherapy
procedure will be performed during endoscopy. Each SCT procedure will be performed
endoscopically at clinically indicated intervals of 6 weeks +/- 3 weeks. Total procedure
dosimetry will be delivered at the discretion of the Investigator based on tumor location and
patient tolerability. After each procedure at defined intervals, patients will be contacted
and QOL symptom related information will be collected. If at any point an Investigator
determines that a subject is not a candidate for further spray cryotherapy or is unable to
tolerate additional procedures, they will be contacted via telephone to ascertain HRQOL
information. Subject participation will last up to two years or until death and enrollment is
anticipated to take 12 months.

Inclusion Criteria:

- Males and females of 18 to 89 years of age.

- Subject is able to read, understand, and sign a written Informed Consent to
participate in the study.

- Subject has persistent esophageal cancer with local luminal involvement and who is not
a surgical candidate or has completed or declined systemic therapy.

- Subject is able to tolerate endoscopy

Exclusion Criteria:

- Subject is pregnant, nursing, or planning to get pregnant during study duration.

- Subjects with an esophageal stent in situ at the time of study enrollment

- Subject, as deemed by treating investigator has contraindication to endoscopy or Spray
Cryotherapy Procedure.

- Subject has received radiation within the past 6 weeks

- Subject has received chemotherapy within the past 2 weeks

- Subject has participated in another clinical study for systemic therapy within 6 weeks
of baseline.

- Subject has had previous Spray Cryotherapy for esophageal cancer.