Inclusion Criteria:

- Patient is above 18 years old.

- Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).

- Patient's fibroadenoma can be visualized with ultrasound.

- Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.

- Patient is able to visit the clinic as needed during the 12-month follow-up period
following the cryoablation procedure.

- The patient has been informed of the study and agrees to its provisions, and has
signed an IRB/EC approved written informed consent, including data privacy
authorization.

Exclusion Criteria:

- Patients with history of breast cancer.

- Women with known pregnancy.

- Patients with superficial fibroadenoma very close to the skin.

- Patient has undergone major surgery within the previous 12 weeks.

- Patients with any terminal illness, or with a life expectancy <2 year.

- Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.

- Patient participating in other trials using drugs or devices.