Interventional Cryotherapy for the Eradication of Benign Airway Disease ("ICE the BAD")

The proposed study is a single center pilot study consisting of up to 10 subjects with
benign airway disease. Treatment dosimetry will be up to 4, 5-second spray cycles. Subjects
will have initial cryospray treatment at Day 0. Subjects will undergo repeat bronchoscopy in
the first three to seven days after the initial treatment, to check for mucosal sloughing
and to reassess luminal patency of the airway. Subjects may undergo up to one bronchoscopy
per week with CSA therapy for a total of four (4) treatments in the first month. If they
present with symptoms thereafter, then a repeat bronchoscopy will be performed; if luminal
obstruction is noted, then the subject will begin the treatment protocol again. If disease
exists bilaterally, only one side will be sprayed initially.

Inclusion Criteria:

- 18 years of age

- Deemed a candidate for cryotherapy based on physician physical or medical history
review

- Deemed operable based on institutional criteria.

Exclusion Criteria:

- Pregnant or nursing

- Planning to sire a child while enrolled in the study

- Known history of unresolved drug or alcohol dependency that would limit ability to
comprehend or follow instructions related to informed consent, post-treatment
instructions, or follow-up guidelines.

- Refusal or inability to give consent.

- Concurrent chemotherapy.

- Prior radiation therapy which involved the any area between the vocal chords and the
diaphragm

- Medical contraindication or potential problem that would preclude study participation

- Concurrent participation in other experimental studies Uncontrolled coagulopathy or
bleeding diathesis

Serious medical illness, including:

- Uncontrolled congestive heart failure

- Uncontrolled angina

- Myocardial infarction

- Cerebrovascular accident within 6 months prior to study entry